Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-24 @ 3:53 AM
Study NCT ID:
NCT02831192
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2016-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microtransplantation in Older Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2016-07-03', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft versus host disease', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 years'}, {'measure': 'leukemia free survival', 'timeFrame': '2 years'}, {'measure': 'complete remission rate', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* de novo acute myeloid leukemia\n* age 60-90\n* have HLA mismatched donor\n\nExclusion Criteria:\n\n* have no suitable donor or donor refused\n* patient refused to accept donor cells'}, 'identificationModule': {'nctId': 'NCT02831192', 'briefTitle': 'Microtransplantation in Older Patients With Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences'}, 'officialTitle': 'International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)', 'orgStudyIdInfo': {'id': 'EAML-MST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MST（microtransplantation）', 'interventionNames': ['Biological: microtransplantation']}], 'interventions': [{'name': 'microtransplantation', 'type': 'BIOLOGICAL', 'description': 'HLA mismatched donor mobilized prepheral stem cell infusion', 'armGroupLabels': ['MST（microtransplantation）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Affiliated Hospital of Academy of Military Medical Sciences ,', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'AI huisheng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}